Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heidelberg University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the role of the LungPoint VBN System in the bronchoscopic access to a target location.
The evaluation will explore:
Multi-center, prospective, single-arm study. The Study will take the form of a User Evaluation. The Evaluation will require the user to perform several standardized functions (e.g. peripheral lesion sampling, lymph node sampling). In addition, users will be asked about other potential techniques that fall within the intended use of the device.
The evaluation will be conducted in patients who are indicated for procedures that fall within the intended use of the device. Examples of such patients include:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchoscopy, lung neoplasm | Patients who have been recommended for bronchoscopy for the purpose of obtaining a biopsy sample of a central or peripheral pulmonary lesion, diagnosing mediastinal or hilar lymphadenopathy or for lung fiducial placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungPoint Virtual Bronchoscopic Navigation (computer-assisted image-guided bronchoscopic navigation) | Device | LungPoint Virtual Bronchoscopic Navigation is a product that displays images and information to aid bronchoscopists in guiding the bronchoscope and other instruments to a target location in the lung airways. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures | Immediate post-operative (day 0) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study will be conducted in patients who are indicated for procedures that fall within the intended use of the device. Examples of those patient populations are:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Felix Herth, MD, PhD, FCCP | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik | Recruiting | Heidelberg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20802352 | Derived | Eberhardt R, Kahn N, Gompelmann D, Schumann M, Heussel CP, Herth FJ. LungPoint--a new approach to peripheral lesions. J Thorac Oncol. 2010 Oct;5(10):1559-63. doi: 10.1097/JTO.0b013e3181e8b308. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000072281 | Lymphadenopathy |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |